BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9186355 · Received October 14, 2019

    Report

    Report Number
    1710034-2019-01105
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS RETURNED FOR EVALUATION. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9128619. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 5/8/2019. INVESTIGATION SUMMARY: RECEIVED A TOTAL OF (B)(4) UNITS AND 1 EMPTY PACKAGE AS FOLLOWS: 47 UNITS AND THE EMPTY PACKAGE WERE FROM LOT 9140539 AND 3 UNITS WERE FROM LOT 9128619. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS. VISUAL EXAMINATION: NO EVIDENCE OF PHYSICAL-MECHANICAL DAMAGE WAS VISIBLE ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED. THE NEEDLE COVERS WERE MANUALLY REMOVED PER IFU INSTRUCTIONS. THE CATHETERS REMAINED ON THE NEEDLE ASSEMBLIES AND WERE NOT ¿REMOVED¿ WITH THE NEEDLE COVERS. THE ADAPTERS WERE CORRECTLY ASSEMBLED AND NO MIS-ORIENTATION WAS OBSERVED. ALL UNITS WERE VISUALLY INSPECTED TO VERIFY THE HUB WELL CONTAINED ADHESIVE. ALL HUBS HAD ADHESIVE ON THEIR WELLS. ALL NEEDLES WERE MANUALLY PULLED AND PUSHED TO VERIFY NO MOVEMENT OCCURRED ¿ THE NEEDLES REMAINED IN PLACE AND NO MOVEMENT WAS FELT. THE UNITS RECEIVED FOR EVALUATION DID NOT REVEAL ANY MANUFACTURING RELATED FINDINGS THAT WOULD CONTRIBUTE TO THE FAILURES DESCRIBED ON THE EVENT DESCRIPTION. THE ACTUAL UNIT WAS NOT RECEIVED FOR EVALUATION. CONCLUSION(S): ROOT CAUSE NOT DETERMINED ¿ THE UNITS RECEIVED DID NOT REVEAL MANUFACTURING RELATED ISSUES THEREFORE, ROOT CAUSE IS NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE CAME OUT AND STUCK THE NURSE. THIS OCCURRED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412 BATCH NO.: 9140539. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE CATHETER RESULTING IN A NEEDLE STICK TO THE NURSE. WHEN USING THIS PRODUCT FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE 3 INCIDENTS IN WHICH ONE FELL OUT AND STUCK THE REGISTERED NURSE. ISSUE: WHEN USING AN ANGIOCATHER FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE THREE INCIDENTS IN WHICH THIS HAPPENED WITH ONE FALLING AND STICKING THE RN. DEFECT TRACKER WILL BE UPDATED AND COMPLETED WHEN MORE INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD SHIELDED IV CATHETER NEEDLE CAME OUT AND STUCK THE NURSE. THIS OCCURRED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381412, BATCH NO.: 9140539. IT WAS REPORTED THAT THE NEEDLE CAME OUT OF THE CATHETER RESULTING IN A NEEDLE STICK TO THE NURSE. WHEN USING THIS PRODUCT FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE 3 INCIDENTS IN WHICH ONE FELL OUT AND STUCK THE REGISTERED NURSE. WHEN USING AN ANGIOCATHER FOR IV PLACEMENT, THE NEEDLE FELL OUT OF THE CATHETER. THERE WERE THREE INCIDENTS IN WHICH THIS HAPPENED WITH ONE FALLING AND STICKING THE RN. DEFECT TRACKER WILL BE UPDATED AND COMPLETED WHEN MORE INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982323 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9128619 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other